The Recall Desk

Hazard

Manufacturing Defect recalls

917 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 917

  • HighFDA (Drugs)·D-0465-2026·2026-04-22

    Quality Choice Honey Lemon Cough Drops Recalled Due to Manufacturing Quality Concerns

    Quality Choice Honey Lemon cough drops are being recalled due to manufacturing quality issues identified during an FDA inspection. No illnesses or injuries have been reported.

    Product
    QUALITY CHOICE — QUALITY CHOICE (COUGH DROPS HONEY LEMON SUGAR FREE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0458-2026·2026-04-22

    Caring Mill Menthol Cough Drops Recalled Following Manufacturing Inspection

    Caring Mill Cough Drops (Menthol) distributed nationwide are being recalled following observations noted during an FDA manufacturing facility inspection on August 15, 2025. The affected product has lot number 20241030 and expiration date October 30, 2026.

    Product
    CARING MILL COUGH DROPS CHERRY — CARING MILL COUGH DROPS CHERRY (MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0451-2026·2026-04-22

    Cinacalcet prescription drug recalled for nitrosamine impurity and manufacturing deviations

    Cipla USA is recalling Cinacalcet Hydrochloride tablets due to the presence of N-Nitroso Cinacalcet above acceptable daily intake limits and manufacturing process deviations. The recall affects 63,192 bottles distributed nationwide.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0457-2026·2026-04-22

    Menthol Flavor Cough Drops Recalled for Quality Defect

    The FDA is recalling Menthol Flavor Cough Drops (Lot #20241030) manufactured for military exchanges due to quality observations identified during a facility inspection on August 15, 2025.

    Product
    MENTHOL FLAVOR COUGH DROP — MENTHOL FLAVOR COUGH DROP (MENTHOL FLAVOR COUGH DROP)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2026·2026-04-15

    MicroScan Neg MIC 3J Diagnostic Panels Recalled for Manufacturing Defects

    Beckman Coulter is recalling MicroScan Neg MIC 3J diagnostic panels due to manufacturing errors affecting test accuracy. One well per panel is missing a required drug while others contain double the intended amount of antibiotics.

    Product
    MicroScan Neg MIC 3J REF C54814
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0445-2026·2026-04-15

    Isotretinoin 30 mg capsules recalled due to potency variation

    Teva Pharmaceuticals is recalling Isotretinoin 30 mg capsules with potency defects. Affected lots contain capsules that are either superpotent or subpotent from normal specifications.

    Product
    ISOTRETINOIN — ISOTRETINOIN (ISOTRETINOIN)
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0423-2026·2026-04-15

    Lanreotide Acetate Injection Recalled Due to Sterility Assurance Deficiency

    Cipla USA recalls Lanreotide Acetate Injection nationwide due to manufacturing deficiencies in visual inspection procedures affecting sterile assurance. No illnesses have been reported.

    Product
    LANREOTIDE ACETATE — LANREOTIDE ACETATE (LANREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0422-2026·2026-04-15

    FDA Recalls Lanreotide Acetate Injection Due to Sterility Assurance Deficiency

    Cipla USA is recalling 54,583 units of Lanreotide Acetate injection (120 mg/0.5 mL) nationwide. The FDA identified deficiencies in visual inspection procedures at the contract manufacturing site that could compromise sterility assurance.

    Product
    LANREOTIDE ACETATE — LANREOTIDE ACETATE (LANREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2026·2026-04-15

    MicroScan Diagnostic Device Recalled for Manufacturing Defect in Antimicrobial Susceptibility Test

    Beckman Coulter is recalling MicroScan Neg Multidrug Resistant test kits due to incorrect manufacturing processing of the in vitro antimicrobial test. The defect may affect diagnostic accuracy.

    Product
    MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agen
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1655-2026·2026-04-08

    Paradise Renal Denervation Catheter Recalled for Nonconforming Device Distribution

    ReCor Medical is recalling the Paradise Ultrasound Renal Denervation System catheter (Lot M4862) because it distributed 24 nonconforming units that were not approved for human use.

    Product
    Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2026·2026-04-01

    Orthalign Drill Plate Recalled for Out-of-Specification Manufacturing Defect

    Orthalign, Inc. is recalling drill plates used in the Lantern Knee System due to manufacturing defects that can result in excessive bone cuts during surgery. Seven units were distributed in Utah.

    Product
    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1633-2026·2026-04-01

    Straumann Custom Titanium Abutments Recalled for Incorrect Raw Material

    Straumann USA recalled 7 Custom Abutment AS Ti units due to a manufacturing error in which a TAN material bar was incorrectly used instead of titanium.

    Product
    Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0405-2026·2026-04-01

    Octreotide Acetate Injection Recalled Due to Sterility Assurance Quality Deficiency

    Teva Pharmaceuticals is recalling 19,869 cartons of Octreotide Acetate injection due to quality system deficiencies at the manufacturer that affect sterility assurance. The FDA discovered these deficiencies during a routine inspection.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0418-2026·2026-04-01

    FDA recalls Meclizine Hydrochloride tablets for manufacturing specification failure

    Amerisource Health Services LLC is recalling Meclizine Hydrochloride tablets due to failed tablet specifications affecting Lot #1024852. Patients should verify their lot number and consult their healthcare provider.

    Product
    MECLIZINE HYDROCHLORIDE — MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2026·2026-03-25

    ConvaTec EsteemBody Drainable Pouch may leak due to manufacturing defect

    ConvaTec EsteemBody Drainable Pouches may leak due to a manufacturing defect. The affected products (Ref 423643, 10-45mm, UDI 00768455221264, lots 5K00011 and 5K00714) are distributed worldwide.

    Product
    Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2026·2026-03-25

    ConvaTec EsteemBody Drainable Pouch recalled due to manufacturing defect

    ConvaTec is recalling EsteemBody Drainable Pouch (10-35mm, Lot 5K01728) because a manufacturing issue may cause the pouch to leak. No illnesses or injuries have been reported.

    Product
    Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0373-2026·2026-03-11

    Hand Sanitizing Wipes Recalled for Manufacturing Compliance Deviations

    Acme United Corporation is voluntarily recalling First Aid Only Hand Sanitizing Wipes nationwide due to manufacturing process deviations. No injuries or illnesses have been reported.

    Product
    FIRST AID ONLY HAND SANITIZING WIPE — FIRST AID ONLY HAND SANITIZING WIPE (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0359-2026·2026-03-11

    First Aid Only BZK Antiseptic Towelettes Recalled for Manufacturing Deviations

    ACME United Corporation is recalling First Aid Only BZK Antiseptic Towelettes nationwide due to manufacturing practice deviations. The firm initiated this voluntary recall to address quality control issues.

    Product
    FIRST AID ONLY BZK ANTISEPTIC — FIRST AID ONLY BZK ANTISEPTIC (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0377-2026·2026-03-11

    Hand Sanitizing Wipe Recall Due to Manufacturing Practice Deviations

    Children's Healthcare of Atlanta hand sanitizing wipes are recalled due to manufacturing practice deviations. Affected lots were distributed nationwide; no illnesses have been reported.

    Product
    Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0360-2026·2026-03-11

    OTC Drug Topical Antiseptic Recalled for Manufacturing Quality Violations

    ACME United Corporation is recalling BZK Antiseptic Towelettes nationwide due to Current Good Manufacturing Practice (CGMP) violations. The firm initiated this voluntary recall to address manufacturing process deviations.

    Product
    BZK TOWELETTE — BZK TOWELETTE (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0378-2026·2026-03-11

    Antimicrobial Hand Wipes Recalled for Manufacturing Practice Deviations

    ACME UNITED CORPORATION is voluntarily recalling Antimicrobial Alcohol Hand Wipes nationwide due to manufacturing practice deviations. The company initiated this recall in January 2026.

    Product
    Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0347-2026·2026-03-04

    FDA Recalls Vista Hypromellose Eye Drops Due to Sterility Manufacturing Defects

    Vista Hypromellose eye drops have been recalled nationwide due to sterility assurance failures and noncompliance with manufacturing standards. Approximately 17,280 cartons are affected.

    Product
    VISTA HYPROMELLOSE DRY EYE RELIEF — VISTA HYPROMELLOSE DRY EYE RELIEF (HYPROMELLOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0346-2026·2026-03-04

    Vista Tears Eye Drops Recalled for Lack of Sterile Manufacturing

    Vista Tears polyethylene glycol 400 and propylene glycol 0.3% eye drops are recalled nationwide due to failure to assure sterile manufacturing conditions. Consumers should stop using the product and contact their healthcare provider if they have experienced eye problems.

    Product
    Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0352-2026·2026-03-04

    BioGlo Fluorescein Sodium Ophthalmic Strips Recalled for Sterility Concerns

    The FDA has recalled 184,320 containers of BioGlo Fluorescein Sodium Ophthalmic Strips nationwide due to lack of sterility assurance resulting from manufacturing non-compliance. Consumers should stop using the product and consult a healthcare provider.

    Product
    BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E
    Category
    Drug
    Distribution
    Distributed nationwide